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| Name | Class |
|---|---|
| Avanos Medical | OTHER |
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A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.
Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Blind Technique of Tube placement | Active Comparator | FDA approved technique of enteral nutrition tube placement |
|
| CORTRAK enteral access system (CEAS) placement | Active Comparator | An electromagnetic device used to enable enteral nutrition tube placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric Tube | Device | A post pyloric feeding tube used in patients requiring enteral nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Time | Time taken for placement of enteral tube | Baseline to End of procedure up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of X-Rays | Number of X-rays required to achieve correct tube placement | Baseline to End of procedure up to 30 minutes |
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Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria
Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Meyer, MD | University of Texas Health San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32994178 | Derived | Jha P, Rupp L, Bonilla L, Gelfond J, Shah JN, Meyer AD. Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children. Pediatrics. 2020 Oct;146(4):e20193773. doi: 10.1542/peds.2019-3773. |
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De-identified data is available to all researchers upon contact of sponsoring organization and investigator Andrew D. Meyer.
Data will be available after primary manuscript is accepted for publication.
Data will be available in journal publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Blind Technique of Tube Placement | FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition |
| FG001 | CORTRAK Enteral Access System (CEAS) Placement | An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects admitted to hospital requiring feeding tube placement
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Blind Technique of Tube Placement | FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition |
| BG001 | CORTRAK Enteral Access System (CEAS) Placement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Time | Time taken for placement of enteral tube | Posted | Median | Inter-Quartile Range | Minutes | Baseline to End of procedure up to 30 minutes |
|
Baseline to End of procedure (tube placement)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Blind Technique of Tube Placement | FDA approved technique of enteral nutrition tube placement Enteric Tube: A post pyloric feeding tube used in patients requiring enteral nutrition |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prashant Jha | Children's Hospital of Nevada at UMC | 702-383-2420 | prashant.jha@umcsn.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2017 | Jan 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| CORTRAK enteral access system | Device | Electromagnetic guidance system for enteric feeding tube placement |
|
|
An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of X-Rays | Number of X-rays required to achieve correct tube placement | Posted | Mean | Full Range | x-rays | Baseline to End of procedure up to 30 minutes |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | CORTRAK Enteral Access System (CEAS) Placement | An electromagnetic device used to enable enteral nutrition tube placement CORTRAK enteral access system: Electromagnetic guidance system for enteric feeding tube placement | 0 | 28 | 0 | 28 | 0 | 28 |
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